The following data is part of a premarket notification filed by Harry A. Schlakman with the FDA for Moss(r) Steel Breakaway(r) Introducer.
Device ID | K945480 |
510k Number | K945480 |
Device Name: | MOSS(R) STEEL BREAKAWAY(R) INTRODUCER |
Classification | Catheter, Suprapubic (and Accessories) |
Applicant | HARRY A. SCHLAKMAN 301 VERONA AVE. Elizabeth, NJ 07208 |
Contact | Harry A Schlakman |
Correspondent | Harry A Schlakman HARRY A. SCHLAKMAN 301 VERONA AVE. Elizabeth, NJ 07208 |
Product Code | KOB |
CFR Regulation Number | 876.5090 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-11-08 |
Decision Date | 1995-08-28 |